196 
and Drug Administration over investigational new drugs in humans, where 
there is a very elaborate procedure which requires submission of a plan 
every time any experiment is carried out, and governmental approval of that 
plan beforehand. I am not persuaded that that is necessary in order to 
exert adequate control in this field. 
But what would be a possibility? One would be to try to get the Fed- 
eral guidelines imposed in the same way that the Equal Employment Opportu- 
nity requirements have been imposed throughout the private sector, namely 
by saying to anyone who has any contract with the Federal Government that 
they must follow these requirements. That has been fairly successful. I 
must confess I am not sufficiently familiar with the legal basis for that, 
that I could give you much comment on that, but I certainly think that is 
one possibility. 
A second would be to set up a central agency in NIH or the National 
Academy or some other group to monitor on a voluntary basis all research. I 
find that a little more difficult. I think it would be somewhat clumsy and 
subject to the same difficulties as the guidelines themselves. It would be 
a bit too voluntary. 
One other possibility which I think does have some promise would be to 
use a somewhat obscure provision of the existing law, which I am sure most 
of you are not familiar with, and I brought along a copy to illustrate how 
it could be used, is Section 361 of the Public Health Service Act, which was 
enacted many, many years ago to control communicable diseases. After all, 
what we are concerned about here is the possibility of unleashing something 
which would be contagious. 
Now, I will just read one sentence from this. "The Surgeon General 
with the approval of the Secretary is authorized to make and enforce such 
regulations as in his judgment are necessary to prevent the introduction, 
transmission or spread of communicable diseases from foreign countries into 
the states or possessions, or, from one State or possession into any other 
State or possession." And for this purpose he can promulgate whatever 
regulations are necessary. 
It is a very, very broad, ill-defined provision. It has been used in 
the past in a variety of situations, all the way down to and including the 
Food and Drug Administration's regulation of pet turtles in order to prevent 
Salmonella . But it has never been interpreted narrowly, and in my judgment 
would allow one of two possible means of control if HEW wished to use it. 
One would be to license, require licensing of all laboratories engaging 
in this type of research, and that licensing would be conditioned upon fol- 
lowing what we now refer to as the guidelines, which obviously would have to 
become regulations. 
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